Senior Manufacturing Mechanical Engineer - Sunnyvale, United States - Intuitive

Description

Company Description

At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges.

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's help to advance the world of minimally invasive care.

Job Description

Primary Function of Position:

This Senior Manufacturing-Mechanical Engineer (Senior Manufacturing Engineer) position reports to the Manufacturing Engineering Director for the Da Vinci Multi Port Surgical System. In this position, the Senior Manufacturing Engineer utilizes their in-depth manufacturing, equipment, and design knowledge to collaborate with design engineering to discover, define, develop, and validate new assembly and test equipment along with assembly process solutions. Their primary focus is to develop assembly and test processes, establish engineering requirements, consider process risks, and identify solutions to guide development. Ultimately, they implement and optimize assembly process equipment, fixturing, and test solutions. They focus on opportunities for poka-yoke, DfX, semi-automated and automated solutions, and design for assembly opportunities to achieve optimal safety, reliability, serviceability, manufacturability, and cost. After production release, and as needed for current released products, they act as the "first line of defense" by providing sustaining support to the manufacturing line while driving continuous improvement of manufacturing processes, equipment, and maintenance procedures. They perform comprehensive failure analysis to identify root cause of emergent production issues, efficiently documenting, mitigating, and closing of non-conformances, and performing requalification of production equipment.

Roles and Responsibilities:

• Strong mechanical engineering skills with demonstrated proficiency in manual assembly techniques. Mechanical design experience is required.
• In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
• Proven diverse capability to adapt and work with support teams on software, algorithms, electronics aspects of the device, and human interface needs.
• Proactively evaluates and challenges designs for technical merit, reliability, serviceability, and manufacturability while working with design partners to realize optimal outcomes.
• Provides a voice for the manufacturing process of Intuitive's products. Leads product and process DfX (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
• Proven ability to identify and assess potential process risks and mitigations and maintain currency of process FMEA and other quality records.
• Own and drive continuous improvement of quality, throughput, and cost during development and after product market release. Utilize analytical objective data and statistical analysis to inform and drive decisions.
• Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflows and detailed work instructions. This includes developing the process flow at the unit operation level, creating manufacturing process instructions (MPIs), and developing requirements for processes and test equipment.
• Responsible for the validation, qualification, and documentation of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).
• Provides technical support for failure analysis of discrepant production components, assemblies, and field returns. Leads investigations with a cross-functional team to identify root cause, determine mitigations, and drive implementation using tools such as 8D, DMAIC, 5-Why, Fishbones, etc..
• Committed to delivering top tier manufacturing processes for new products. This includes developing and driving project milestones and schedules, resolving manufacturability issues and root cause analysis, to improvement throughput, yield and efficiency.
• Strong CAD skillset with vision for mechanical assembly critique and for fixture creation.
• Designs, document, assemble, qualify and implement mechanical assembly/test/inspection fixtures and equipment.
• Provides product and process DFA (Design for Assembly) input to Product Development Engineering to focus on manufacturability and reduce variation.
• Creates a repeatable and efficient "low-volume" manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions.
• Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and ECO/NCO/MCO writing, reviewing and implementation.
• Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
• Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
• Mentors and sets project tasks for Mfg Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.

Qualifications

Skill/Job Requirements:

• 4 yr. degree in Mechanical Engineering. MSME preferred
• 8+ years experience as design or manufacturing engineer supporting product with significant mechanical content (MSME with 5 years also considered).
• Demonstrated understanding of manufacturing processes including injection molding, machining, stamping and Process Engineering capability
• Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
• Electromechanical new product development experience preferred
• Solid modeling/CAD experience (SolidWorks preferred)
• Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments
• Excellent communication, organization, follow-up and documentation skills
• Comfortable interacting with technicians, engineers, and management all on a regular basis
• Strong technical skills in prototyping, tooling development and troubleshooting
• ISO13485 or experience in medical device manufacturing environment
• Machine tool experience a plus

We are an AA/EEO/Veterans/Disabled employer.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.